Status:
COMPLETED
Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
Lead Sponsor:
University of Michigan
Conditions:
Obstructive Sleep Apnea
Hypercapnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
* Patients with spinal cord injury (SCI) usually breathe without any mechanical assistance, but significant breathing problems occur often during sleep, either because the upper airway closes (obstruc...
Detailed Description
Eligible subjects will sign informed consent, followed by: a 4 month period of maintaining a daily log of symptoms and medical events (such as hospitalization, starting antibiotics). An overnight sl...
Eligibility Criteria
Inclusion
- 18 years or older
- C1-T6 spinal cord injury for at least 3 months
- living within 100 miles of Ann Arbor, Michigan, USA
Exclusion
- unable to provide informed consent
- comorbid condition that limits life expectancy to less than 1 year
- ventilator-dependent
- established diagnosis of sleep-disordered breathing
- prior use of noninvasive positive pressure ventilation (CPAP or BiPAP) for any reason (temporary suse of noninvasive ventilation during a hospitalization is permissible if it was discontinued more than 3 months prior to enrollment)
- active duty military personnel
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01882257
Start Date
October 1 2011
End Date
February 1 2016
Last Update
January 11 2017
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109